NCT02096250

Brief Summary

The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

March 21, 2014

Last Update Submit

September 22, 2015

Conditions

Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • Iron absorption

    14 days after test meal consumption

Study Arms (3)

NaFeEDTA

EXPERIMENTAL

NaFeEDTA

Other: NaFeEDTA

Ferrous fumarate

EXPERIMENTAL

Ferrous fumarate

Other: Ferrous fumarate

NaFeEDTA + ferrous fumarate

EXPERIMENTAL

NaFeEDTA + ferrous fumarate

Other: NaFeEDTA + ferrous fumarate

Interventions

NaFeEDTAOTHER
NaFeEDTA
Ferrous fumarateOTHER
Ferrous fumarate
NaFeEDTA + ferrous fumarateOTHER
NaFeEDTA + ferrous fumarate

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age (18 to 45 years)
  • Generally healthy
  • Consenting to study participation

You may not qualify if:

  • Pregnancy or lactation
  • Weight \>65 kg
  • Chronic illnesses which may influence iron absorption
  • Severe anemia (Hb\<10 g/dl)
  • Age 4 years +/- 12 months
  • Generally healthy
  • Severe anemia (Hb\<10 g/dl)
  • Weight for height \< -2 Z scores (wasting)
  • Height of age \< -2 Z score (stunting)
  • Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)
  • Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)
  • Allergies or intolerances relevant to the test meal (gluten)
  • Blood donation or major blood losses during the 2 months prior to the study
  • Illness during the 4 weeks prior to the study (will be judged by investigator)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministère de la Santé Publique et de la Population

Port-au-Prince, Haiti

Location

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Fe(III)-EDTAferrous fumarate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Isabelle Aeberli, PhD

    ETH Zurich (Switzerland)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

July 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

HA(1)